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Teaching Math Skills to Individuals With Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT01204151
Recruitment Status : Unknown
Verified September 2010 by Stanford University.
Recruitment status was:  Recruiting
First Posted : September 17, 2010
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Children with FXS are predisposed to manifesting a particular profile of intellectual strengths and weaknesses, including specific deficits in math, visual-spatial skills, executive functioning, and social skills. Until now, intensive behavioral interventions have not been targeted to syndrome-specific weaknesses. In the present study we will develop and evaluate behavioral strategies to aid skill acquisition in children with FXS.

Condition or disease Intervention/treatment
Developmental Disabilities Fragile X Syndrome Behavioral: discrete-trial training

Detailed Description:

There are no experimental data of skill acquisition using matching-to-sample techniques (or any other specific cognitive intervention) conducted with individuals with FXS. Further, no studies have been conducted to examine the possible underlying or mediating brain processes involved during matching-to-sample skill acquisition in children with FXS or any other neurodevelopmental disorder.

Previous pilot data have indicated that the computerized match-to-sample procedure, even when conducted in time-limited sessions, may significantly help individuals with FXS learn new skills. We plan to utilize brain imaging methodology to compare functional connectivity networks for those who pass and those who fail the equivalence test. 30 subjects with FXS and 30 control subjects with idiopathic developmental disability will be enrolled in the study. All subjects will be enrolled at Stanford.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating a Brief Intensive Intervention for Individuals With Fragile X Syndrome
Study Start Date : September 2008
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Percent correct [ Time Frame: 2 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (a) 10 to 23 years of age (this age range was chosen to maximize the probability that subjects will cooperate with the imaging procedures as well as benefit from the interventions),
  • (b) in good physical health,
  • (c) able to participate in the imaging component of the project,
  • (d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points are generally unable to comply with the scanning procedures.
  • (e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for control group).

Exclusion Criteria:

Exclusion criteria include

  • contraindications for MRI (e.g., pacemaker, braces),
  • the presence of neurological or sensory problems not associated with the conditions of interest (e.g., head trauma, blindness), or inability to discontinue psychotropic medication for 4 weeks prior to the scan.
  • Additional exclusion criteria for the control group include the presence of any known identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome, Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204151


Contacts
Contact: Scott Hall, PhD (650) 498-4799 hallss@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Scott Hall, PhD    650-498-4799    hallss@stanford.edu   
Principal Investigator: Scott Hall         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Scott Hall Stanford University
More Information

Responsible Party: Scott Hall, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01204151     History of Changes
Other Study ID Numbers: SU-09132010-6849
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Fragile X Syndrome
Syndrome
Developmental Disabilities
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Neurodevelopmental Disorders
Mental Disorders